Mitomycin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Gastric cancer; Pancreatic cancer; Metastatic breast cancer; Non-small cell lung cancer; Head and neck cancer; Prostate cancer Dosage requirement is individualised according to local protocols (refer to detailed product guideline). Usual dose: 10-20 mg/m2 may be repeated at intervals of 6-8 weeks if blood counts permit and may be adjusted according to previous haematological response. Alternatively, 4-10 mg (0.06-0.15 mg/kg) at 1-6 weekly intervals. Intravesical Superficial bladder tumours Usual dose: 20-40 mg instilled once weekly or 3 times a week for a total of 20 doses. Alternatively, 4-10 mg (0.06-0.15 mg/kg) instilled once weekly or 3 times a week. Ophthalmic Adjunct in ophthalmic surgery As 0.2 mg/mL solution: Apply via saturated sponges to the surgical site of glaucoma filtration surgery for 2 minutes.
Dosage Details
Intravenous
Cancer, pancreatic, Gastric cancer, Head and neck cancer, Metastatic breast cancer, Non-small cell lung cancer, Prostate cancer
Adult: Dosage requirement is individualised according to local protocols (refer to detailed product guideline). Usual dose: 10-20 mg/m2 may be repeated at intervals of 6-8 weeks if blood counts permit and may be adjusted according to previous haematological response. Alternatively, 4-10 mg (0.06-0.15 mg/kg) at 1-6 weekly intervals.

Intravesical
Superficial bladder tumours
Adult: Usual dose: 20-40 mg instilled once weekly or 3 times a week for a total of 20 doses. Retain solution in the bladder for at least 1 hour by rotating dose contact with all areas of the bladder urothelium every 15 minutes. Alternatively, 4-10 mg (0.06-0.15 mg/kg) instilled once weekly or 3 times a week. For prophylaxis of recurrent cases: 20 mg every 2 weeks or 40 mg monthly or 3-monthly.

Ophthalmic
Adjunct in ophthalmic surgery
Adult: As 0.2 mg/mL solution: Apply via saturated sponges to the surgical site of glaucoma filtration surgery. Keep the sponges on the treatment area for 2 minutes.
Reconstitution
Intravenous:
Dilute with sterile water for inj to a final concentration of 0.5 mg/mL. May further dilute in 0.9% NaCl or Na lactate to a concentration of 0.02-0.04 mg/mL.
Ophthalmic:
Reconstitute 0.2 mg with 1 mL of sterile water for inj, then shake to dissolve. Allow to stand at room temperature until the product has dissolved into solution.
Incompatibility
Incompatible with highly acidic substances.
Contraindications
Hypersensitivity to mitomycin. Thrombocytopenia, coagulation disorders, increased bleeding tendency, acute infections, serum creatinine >1.7 mg/dL. Pregnancy and lactation.
Special Precautions
Patient with bone marrow suppression (platelet count <100,000/mm3, WBC <4,000/mm3, or progressive decline in either), infections (e.g. varicella infection). Phakic patients (ophthalmic). Patients receiving blood product transfusions. Renal and hepatic impairment.
Adverse Reactions
Significant: Bone marrow suppression (e.g. leucopenia, thrombocytopenia), renal toxicity, local ulceration and cellulitis (IV), shock or anaphylactoid reaction (e.g. itching, rash, dyspnoea, flushing), neurologic abnormalities. Ophthalmic: Corneal or scleral damage (when given in doses >0.2 mg/mL or used for longer than 2 minutes), post-operative hypotony.
Eye disorders: Retinal vein occlusion, conjunctival necrosis, haemorrhage (retinal, subconjunctival, suprachoroidal, vitreal), bleb-related infection.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, stomatitis.
General disorders and admin site conditions: Malaise, pyrexia, asthenia.
Injury, poisoning and procedural complications: Vascular pain, phlebitis, thrombus, induration or necrosis at the inj site.
Investigations: Increased serum creatinine.
Metabolism and nutrition disorders: Anorexia.
Renal and urinary disorders: Intravesical: Cystitis, bladder fibrosis or contracted bladder (e.g. pollakiuria, dysuria), calcinosis.
Skin and subcutaneous tissue disorders: Palmar plantar erythrodysaesthesia, alopecia, pruritus, rash.
Vascular disorders: Hypertension.
Potentially Fatal: Haemolytic-uraemic syndrome, sepsis, pulmonary toxicities (e.g. pulmonary oedema, interstitial pneumonia, pulmonary fibrosis, pulmonary hypertension, pulmonary venoocclusive disease).
Patient Counseling Information
This drug may cause weakness and lethargy, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor renal function (e.g. serum creatinine) prior to treatment and after each course, CBC with differential during therapy and for ≥8 weeks following therapy; liver and pulmonary function tests frequently.
Overdosage
Symptoms: Increased adverse effects such as fever, nausea, vomiting, myelosuppression. Management: Supportive treatment.
Drug Interactions
Concomitant use with other chemotherapy agents (e.g. vinca alkaloids) may enhance adverse effects e.g. pulmonary toxicity, bone marrow suppression.
Action
Description: Mitomycin, a highly toxic antineoplastic antibiotic, selectively inhibits the synthesis of deoxyribonucleic acid (DNA) by alkylating DNA to produce DNA cross-linking (primarily with guanine and cytosine pairs). It also suppresses cellular ribonucleic acid (RNA)  synthesis at high concentrations. Although it is not a cell cycle-specific agent, it is most active in the late G1 and early S phases.
Pharmacokinetics:
Distribution: Widely distributed.
Metabolism: Metabolised primarily in the liver.
Excretion: Mainly via faeces; urine (approx 10%, as unchanged drug).  Terminal half-life: Approx 50 minutes.
Chemical Structure

Chemical Structure Image
Mitomycin

Source: National Center for Biotechnology Information. PubChem Database. Mitomycin, CID=5746, https://pubchem.ncbi.nlm.nih.gov/compound/Mitomycin (accessed on Jan. 22, 2020)

Storage
IV: Store at 25°C. Protect from excessive heat >40°C. Reconstituted solution: Store at room temperature with stability of 7 days or refrigerate at 2-8°C with stability of 14 days. Protect from light. Ophthalmic: Store between 20-25°C. Protect from excessive heat and light. Reconstituted solution is stable for 1 hour at room temperature. This is a cytotoxic drug. Any unused portions should be disposed of in accordance with local requirements.
ATC Classification
L01DC03 - mitomycin ; Belongs to the class of other cytotoxic antibiotics. Used in the treatment of cancer.
References
Anon. Mitomycin (Ophthalmic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 11/09/2019.

Anon. Mitomycin (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 11/09/2019.

Buckingham R (ed). Mitomycin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/06/2014.

Mitomycin Injection (West-Ward Pharmaceuticals Corp). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 11/09/2019.

Mitomycin Powder for Solution for Injection/Infusion (Substipharm Limited). MHRA. https://products.mhra.gov.uk/. Accessed 11/09/2019.

Mitosol Solution (Mobius Therapeutics LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 11/09/2019.

Mitosol Solution (Mobius Therapeutics, LLC). U.S. FDA. https://www.fda.gov/. Accessed 11/09/2019.

Disclaimer: This information is independently developed by MIMS based on Mitomycin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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